Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH

NCT ID: NCT04347460

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-27

Study Completion Date

2020-08-31

Brief Summary

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SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. A considerable amount of patients require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients, which is not a typical finding in virus associated pneumonia. The H-score and the modified HLH 2004 score offer diagnostic tools, that help establishing the diagnosis of HLH. Even more important is the expert clinical judgment to establish the diagnosis of sHLH.

Detailed Description

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SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. The course of disease is relatively mild in most of the patients, but there is a considerable amount of patients that require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients. The H-score and the modified HLH 2004 score offer diagnostic tools, that helps establishing the diagnosis of HLH. Moreover expert clinical judgment is key to establish a diagnosis of sHLH. Still, so far no systematic analysis has been carried out answering the question as to whether or not these patients suffer from secondary HLH and could potentially benefit from immunomodulatory drugs.

Conditions

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COVID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID 19

Patients requiring ICU treatment due to severe COVID 19 interstitial pneumonia or otherwise COVID-19 related disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 17a
* diagnosis of SARS CoV 2 by PCR testing
* Hospitalized due to clinical severity of the disease
* written and informed consent or consent of the family
* GFR\<30 is not an exclusion criterion

* missing written and informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Schmaderer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, TUM Medical School, Klinikum rechts der Isar

Locations

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Department of nephrology, Klinikum rechts der Isar

München, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christoph Schmaderer, M.D.

Role: CONTACT

0049-89-4140 ext. 5231

Philipp Moog, M.D.

Role: CONTACT

0049-89-4140 ext. 5231

Facility Contacts

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Christoph Schmaderer, M.D.

Role: primary

0049-89-4140 ext. 5231

Georg Lorenz, M.D.

Role: backup

0049-89-4140 ext. 5231

Other Identifiers

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161/20 S

Identifier Type: -

Identifier Source: org_study_id

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